HIPAA Interim Final Rule, October 30, 2009
Client Alert | less than 1 min read | 11.06.09
On October 30, 2009, the Department of Health and Human Services (HHS) published an interim final rule conforming HIPAA's enforcement regulations to revisions made under the HITECH Act. The interim final rule strengthens HHS' civil money penalty authority by establishing categories of violations reflecting levels of culpability, increasing the civil penalty amounts, and modifying the affirmative defenses available to covered entities.
Click here to view a presentation on the HIPAA Final Rule [PDF]
Insights
Client Alert | 5 min read | 04.13.26
EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal
In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product.
Client Alert | 4 min read | 04.10.26
CMS Finalizes Rate Notice for Medicare Parts C and D (CY 2027)
Client Alert | 2 min read | 04.10.26
Client Alert | 4 min read | 04.10.26
FTC Issues Five-Year Strategic Plan: What Businesses Need to Know
